Phase II Study of Velcade in Waldenstrom's Macroglobulinemia
- Patients will receive bortezomib intravenously twice weekly for 2 weeks on days 1,4,8
and 11 of each cycle. A 10-day rest period (days 12-21) will follow the 2 weeks of
treatment. The treatment cycle is repeated up to eight times depending upon the disease
response and if the patient is tolerating the drugs.
- The following procedures will be conducted as part of the treatment monitoring: DAY 1
VISIT (of each treatment cycle): evaluation of disease-related symptoms, vital signs
and weight and blood tests. DAY 4 VISIT (of each treatment cycle): vital signs and
blood work. DAY 8 VISIT (of each treatment cycle): vital signs and blood work. DAY 11
VISIT(of each treatment cycle): vital signs, blood work, and possible CT Scan.
- Treatment will be discontinued if any of the following occur: Disease gets worse,
severe side-effects or the patient requires other anti-cancer therapy.
- At the end of the treatment (30 days after the last dose of study drug) the patient
will have a physical exam, vital signs, evaluation of disease-related symptoms, blood
work and CT scan for tumor measurements.
- Long term follow-up consists of every 3 month clinical visits until disease progression
or up to 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
Steven Treon, MD, MA, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Center||Boston, Massachusetts 02115|